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Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.

2014-08-27 03:44:56 | BioPortfolio

Summary

The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug.

This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.

Description

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Osteoarthritis

Intervention

Buprenorphine transdermal patch, Buprenorphine transdermal patch

Location

Edwards Lake Medical Center
Birmingham
Alabama
United States
35235

Status

Terminated

Source

Purdue Pharma LP

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:44:56-0400

Clinical Trials [1812 Associated Clinical Trials listed on BioPortfolio]

Efficacy & Safety of Buprenorphine Transdermal System(BTDS) in Subjects With Moderate to Severe Osteoarthritis (OA) Pain

The purpose of the extension phase is to evaluate the long-term safety and tolerability of BTDS.

Efficacy and Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain

The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of...

Efficacy and Safety of Buprenorphine Transdermal Patch in Non-cancer Pain of Moderate Intensity

This was a phase IV, open-label and single-arm study of patients with non-malignant pain due to osteoarthritis, rheumatoid arthritis, low back pain and joint/muscle pain, who were not resp...

The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) on QT Intervals in Healthy Volunteers

The purpose of this study is to examine the effect of buprenorphine on QT intervals in healthy subjects.

Efficacy and Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain

The purpose of the extension phase is to evaluate the long-term safety and tolerability of BTDS. Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose (up...

PubMed Articles [1276 Associated PubMed Articles listed on BioPortfolio]

Implications of uninterrupted preoperative transdermal buprenorphine use on postoperative pain management.

Buprenorphine is a partial µ-receptor agonist resistant to displacement from receptors by conventional opioids, which can block the effect of conventional opioids and may interfere with postoperative...

Formulation and evaluation of 4-benzylpiperidine drug-in-adhesive matrix type transdermal patch.

The objective of our study was to develop a transdermal patch of 4-benzylpiperidine and to evaluate its in vitro transdermal permeation profile. Appropriate pressure sensitive adhesives and additives ...

Methadone to buprenorphine/naloxone induction without withdrawal utilizing transdermal fentanyl bridge in an inpatient setting-Azar method.

Although buprenorphine/naloxone is widely recognized as first-line therapy for opioid use disorder, the requirement for moderate withdrawal prior to initiation in efforts to avoid precipitated withdra...

Effect of Mild Hyperthermia on Transdermal Absorption of Nicotine from Patches.

Application of heat (hyperthermic conditions) on skin is known to enhance drug transfer and facilitate skin penetration of molecules. The aim of this work was to study the effect of hyperthermia on th...

Safety Problems With a Transdermal Patch for Migraine: Lessons From the Development, Approval, and Marketing Process.

We sought to analyze publicly available information about patient harm associated with an iontophoretic sumatriptan patch, to identify what went wrong and to suggest ways in which similar problems mig...

Medical and Biotech [MESH] Definitions

A medicated adhesive patch placed on the skin to deliver a specific dose of medication into the bloodstream.

An electrophysiologic technique for studying cells, cell membranes, and occasionally isolated organelles. All patch-clamp methods rely on a very high-resistance seal between a micropipette and a membrane; the seal is usually attained by gentle suction. The four most common variants include on-cell patch, inside-out patch, outside-out patch, and whole-cell clamp. Patch-clamp methods are commonly used to voltage clamp, that is control the voltage across the membrane and measure current flow, but current-clamp methods, in which the current is controlled and the voltage is measured, are also used.

A pharmaceutical preparation that combines buprenorphine, an OPIOID ANALGESIC with naloxone, a NARCOTIC ANTAGONIST to reduce the potential for NARCOTIC DEPENDENCE in the treatment of pain. It may also be used for OPIATE SUBSTITUTION THERAPY.

A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.

Skin tests in which the sensitizer is applied to a patch of cotton cloth or gauze held in place for approximately 48-72 hours. It is used for the elicitation of a contact hypersensitivity reaction.

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